Made in Chi­na: TaiMed wins FDA OK for a 'break­through' HIV ther­a­py for drug-re­sis­tant pa­tients

The FDA has hand­ed TaiMed and its part­ners at Ther­at­e­ch­nolo­gies an ap­proval for the first new HIV drug to come along in a decade with a nov­el mech­a­nism of ac­tion.

The drug, to be mar­ket­ed as Trog­a­r­zo (ibal­izum­ab-uiyk), works by bind­ing to the sec­ond ex­tra­cel­lu­lar do­main of the CD4+ T cell re­cep­tor, away from oth­er bind­ing sites used by drugs al­ready on the mar­ket. That ap­proach al­lows pa­tients who are be­com­ing re­sis­tant to their ther­a­pies to add this to the mix be­fore be­ing ex­posed to a lethal amount of virus.

Tai­wan-based TaiMed of­fered enough da­ta from a mid-stage pro­gram to war­rant both a break­through ther­a­py des­ig­na­tion as well as a pri­or­i­ty re­view for this drug, slic­ing the time need­ed for an FDA in­spec­tion.

For a low pro­file ther­a­py, this drug is a re­mark­able trend­set­ter in many ways. Shang­hai-based WuXi Bi­o­log­ics — part of Ge Li’s ex­pan­sive bio­phar­ma em­pire — will man­u­fac­ture the drug, and the FDA com­plet­ed its first-ever in­spec­tion and ap­proval of a Chi­nese man­u­fac­tur­ing fa­cil­i­ty to lay the foun­da­tion for the com­mer­cial roll­out.

“While most pa­tients liv­ing with HIV can be suc­cess­ful­ly treat­ed us­ing a com­bi­na­tion of two or more an­ti­retro­vi­ral drugs, a small per­cent­age of pa­tients who have tak­en many HIV drugs in the past have mul­tidrug re­sis­tant HIV, lim­it­ing their treat­ment op­tions and putting them at a high risk of HIV-re­lat­ed com­pli­ca­tions and pro­gres­sion to death,” said Jeff Mur­ray, deputy di­rec­tor of the Di­vi­sion of An­tivi­ral Prod­ucts in the FDA’s CDER. “Trog­a­r­zo is the first drug in a new class of an­ti­retro­vi­ral med­ica­tions that can pro­vide sig­nif­i­cant ben­e­fit to pa­tients who have run out of HIV treat­ment op­tions. New treat­ment op­tions may be able to im­prove their out­comes.”

TaiMed out-li­censed the drug to Mon­tre­al-based Ther­at­e­ch­nolo­gies a cou­ple of years ago in a deal that starts very small. The biotech bagged just a mil­lion dol­lars, ini­tial­ly, with an­oth­er mil­lion due on launch. There’s a few mil­lion more in shares for var­i­ous con­di­tions, and $10 mil­lion once an­nu­al sales of $200 mil­lion are reached in the US. That goes up to a $100 mil­lion if they can break the $1 bil­lion mark.

Ther­at­e­ch­nolo­gies al­so agreed to a de­vel­op­ment mile­stone for Phase III of $50 mil­lion, paid quar­ter­ly.

In­vestors liked the sound of all of it. Ther­at­e­ch­nolo­gies’ shares $THERF soared 30% on the news.

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Vas Narasimhan, Novartis CEO (Patrick Straub/​EPA-EFE/​Shutterstock)

No­var­tis pays $678M for kick­back scheme as Vas Narasimhan tries to dis­tance phar­ma gi­ant from shady be­hav­ior

Novartis has reached another large settlement to resolve misconduct allegations, agreeing to pay more than $678 million to settle claims that it had spent hundreds of millions of dollars on lavish dinners, so-called speaking fees and expensive alcohol “that were nothing more than bribes” to get doctors to prescribe Novartis medications.

The top-shelf alcohol and lavish meals included a $3,250 per person night at Nobu in Dallas, a $672-per person dinner at Washington DC’s Smith & Wollensky and a $314 per person meal at Sushi Roku in Pasadena, according to the Justice Department complaint. There were at least 7 trips to Hooters and fishing trips in Alaska and off the Florida coast. Each of these events were supposed to be “speaker programs” where doctors educated other doctors on a drug, but the DOJ alleged many were “bogus” wine-and-dine events where the drug was barely mentioned, if at all.  (“Nobody presented slides on the fishing trips,” the complaint says.)

Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

Look­ing for 'ex­ter­nal in­no­va­tion,' Boehringer In­gel­heim re­serves $500M+ for new Shang­hai hub

Now that Boehringer Ingelheim’s bet on contract manufacturing in China has paid off, the German drugmaker is anteing up more to get into the research game.

Boehringer has set aside $507.9 million (€451 million) for a new External Innovation Hub to be built in Shanghai over five years. The site will become one of its “strategic pillars” as the team strives to get 71 approvals — either for new products or indications — by 2030, said Felix Gutsche, president and CEO of Boehringer Ingelheim China.

No­vavax snags Ben Machielse for CMC and pro­motes a trio of staffers; Mar­ty Du­vall lands an­oth­er CEO post at On­copep­tides

Novavax has been making waves recently by securing a $384 million commitment from CEPI to cover R&D and manufacturing for its Covid-19 vaccine while also spending $167 million on a 150,000 square-foot facility. The Maryland biotech continues to shore up its leadership team as well, bringing in Ben Machielse as their EVP of CMC just a couple weeks after nabbing AstraZeneca vet Filip Dubrovsky as their new CMO. Machielse was president and CEO of Vtesse from 2014-17, and before that, he also spent more than 11 years at MedImmune and was EVP of operations for the back half of his tenure.

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